States Study Marketing of Lilly Pill

Stepping up government investigations into Eli Lilly’s
marketing of its best-selling drug Zyprexa, state prosecutors in
Illinois and Vermont have demanded that the company turn over
information about the way it promoted the medication.

On Thursday, lawyers from the consumer protection division of the
Illinois attorney general’s office demanded that Lilly hand over
marketing materials, e-mail messages, and other documents with
information about promotion of Zyprexa. Vermont investigators issued a
similar order yesterday morning.

The orders are the civil equivalents of criminal subpoenas,
according to Deborah Hagan, the chief of the Illinois consumer
protection division.

Illinois and Vermont are now part of a coordinated five-state civil
investigation into the way Lilly promoted Zyprexa, a treatment for schizophrenia and bipolar disorder.
The states are investigating whether Lilly tried to hide Zyprexa’s risk
of causing weight gain and other risks associated with diabetes and whether the company promoted Zyprexa for use in patients who do not have schizophrenia or bipolar disorder.

Federal laws prohibit such so-called “off label” marketing, although
doctors may prescribe any drug for any disease that they believe the
drug will help.

The orders on Thursday and yesterday are the first formal demands
for Lilly documents from state attorneys and they indicate an
escalation of the investigation, according to Ms. Hagan and Julie
Brill, who is an assistant attorney general in Vermont.

“We can ask for documents; we can ask for answers to questions; and
we can ask for people to come in and testify under oath,” Ms. Hagan
said. Federal prosecutors in Philadelphia have also recently
accelerated their own investigation into Lilly’s marketing of Zyprexa.

In a statement yesterday, Lilly said it would cooperate with the
investigations and had done nothing wrong. “We intend to cooperate with
the Illinois attorney general’s civil investigative demand relating to
Zyprexa,” the company said. “We cannot comment further about this or
other ongoing investigations.”

While the investigation being led by Illinois is civil, other
investigations into Lilly’s conduct are both civil and criminal.
Attorneys general in California and Florida may seek to recover
Medicaid payments that the states made for Zyprexa. Medicaid represents
a sizable percentage of the drug’s overall sales because many people
who take the medicine are disabled and do not work.

Any fine or cost recovery could be sizable, because Zyprexa has been
a commercial success. The drug is by far Eli Lilly’s largest-selling
product, with sales of $4.2 billion last year and about $30 billion
since its introduction in 1996. More than 20 million people have taken
Zyprexa since Lilly began selling the drug.

The investigations could continue for months or possibly years,
people involved in the cases say, as investigators sift through tens of
thousands of documents from the company and talk to current and former
employees.

Zyprexa, whose generic name is olanzapine, is a potent chemical that
binds with receptors in the brain to reduce the symptoms of
schizophrenia and bipolar disorder. But Zyprexa also causes severe
weight gain and changes in blood sugar and cholesterol in many patients who take it.

Internal Lilly documents provided to The New York Times last month by a lawyer in Alaska who represents people with mental illness indicate that Lilly has engaged in a decade-long campaign to play down the seriousness of the side effects of Zyprexa.

Lilly did not disclose to doctors that its own data showed that 16
percent of people taking Zyprexa for a year gained more than 66 pounds,
according to the documents.

The documents also indicate that the company told its drug
representatives to promote Zyprexa to doctors for the treatment of
conditions other than bipolar disorder or schizophrenia.

Lilly has said it did not market Zyprexa off-label and said so again in its statement yesterday.

“Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses,” the company said.

But its marketing materials have repeated references to promoting
the drug for other uses. And some sales representatives and doctors
have also said they believed that the company was marketing off-label.

Still, any criminal prosecution of the company could face a high
burden. While settlements of off-label marketing cases have led to
large fines, such cases so far have fizzled if they reach juries.

And as long as drug makers comply with federal requirements to provide data about their products to the Food and Drug Administration,
companies have a relatively strong defense against criminal
prosecution, according to lawyers who are experts in drug marketing.